CSV Specialist

Katalyst Healthcares and Life Sciences is seeking a skilled CSV Specialist to join our team. As a CSV Specialist, you will play a critical role in ensuring the successful implementation of manufacturing and laboratory equipment and computerized systems at our multi-use sites.

• Support the implementation of equipment qualification and systems validation activities.
• Develop and maintain protocols, reports, and other documentation related to equipment qualification and systems validation.
• Collaborate with internal customers and external service providers to ensure compliance with policies, guidelines, and procedures.
• Manage projects of varying scope and complexity, including scheduling, procurement, site prep, installation, qualification, and turnover to business areas.
• Develop and maintain validation/qualification deliverables, such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.
• Provide technical support and guidance on calibration and equipment qualification issues.
• Interface with customers to ensure all expectations are being met.

• Minimum 5 years of experience in FDA-regulated industry, with 5 years' experience in CSV.
• Strong working knowledge of MS Windows client and server technologies.
• Working knowledge of standard networking principles and technologies.
• Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.
• Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.
• Ability to work with the end user to identify and document User and Functional Requirements.
• Knowledge of pharmaceutical laboratory and manufacturing systems.
• Experience executing equipment qualification documents.
• Ability to interact effectively with laboratory, QA, and Facilities groups.
• Strong ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks/assignments with others that may impact timely completion.
• Ability to effectively manage multiple tasks and activities simultaneously.
• Strong written and verbal communication skills along with solid presentation skills.
• Proficient at writing well-formulated emails and reports.
• Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task.
• Ability to effectively communicate with employees, contractors, and vendors.
• Experience with technical writing and document development/generation.
• Strong computer skills in Microsoft Office Suite - Word, Excel, Visio, and Outlook, and the ability to learn new software as required for equipment qualification.